About Us
Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.
A Brief Overview
This role is responsible for executing daily activities in the Microbiology Laboratory including supporting all activities related to microbiological assessment of Merz products, the Merz DI water systems, and the manufacturing environments. Advise Quality Assurance, Manufacturing and R&D departments on matters related to product sterilization and microbial assessment. Evaluate the operation of Manufacturing and Quality Assurance activities in relation to sterilization compliance with quality standards and regulations and recommend where corrections or improvements are indicated. Supports root cause analysis for nonconformity and/or out of specification (OOS) events. Provide direct support to Quality Assurance personnel regarding the operation of the department and Quality System.
What You Will Do
- Quality Testing Perform Endotoxin and Bioburden testing per established procedures. Perform Environmental Monitoring (EM) of the Cleanrooms as required. Perform quality analysis of the water systems for the manufacturing sites as required.
- Documentation Perform quality review for microbiological testing/EM monitoring data. Coordinate and maintain associated databases for all microbiological data and provide support to other departments as required. Monitor microbiological trends in their respective areas and respond appropriately. Write, revise, and review related Standard Operating Procedures (SOPs) and Department related Protocols. Perform root cause analysis for microbial excursions and other microbiology investigations. Write and review investigations of microbial excursions and other microbiology investigations. Monitor the manufacturing and quality assurance activities associated with the sterilization of Merz Aesthetics Medical products.
- Validation Support Maintain an elevated level of expertise in current regulatory requirements, including FDA Quality System Regulations, and ISO standards. Participate in audits and as part of cross-functional teams with other functional areas and facilities as an SME (Subject Matter Expert).
- Manufacturing Support Support sterilization, product, process, environmental and cleaning validations as required to ensure product quality and Quality System requirements are met.
Minimum Requirements
- Bachelor of Science (B.S.).
- Bachelor of Arts (B.A.) in Microbiology, Biology, Physical Science or related field.
Preferred Qualifications
- Experience in Quality Laboratory.
- GLP/GMP experience.
- Pharmaceutical experience and/or other regulated industry or similar experience.
Technical & Functional Skills
- Strong technical and general problem solving skills.
- Strong aseptic technique and understanding of microbiology.
- Training of personnel.
- Experience with the sterilization of medical devices including Steam, EtO, and Gamma processes, and testing methods associated with those processes.
- Familiar with ISO 9000/ISO 13485 Quality System Standards, ISO 14644 Cleanrooms and Associated Controlled Environments, FDA Quality System Regulations, GMPs, and/or other international medical device regulations. Familiarity with ISO standards, USP, EP, and JP.
- Knowledge of activities required to test product and monitor the manufacturing environment for microbiological character.
- Ability to work with company staff and communicate effectively throughout the organization is essential.
- Excellent written and oral communication skills.
Benefits:
- Comprehensive Medical, Dental, and Vision plans
- 20 days of Paid Time Off
- 15 paid holidays
- Paid Sick Leave
- Paid Parental Leave
- 401(k)
- Employee bonuses
- And more!
Your benefits and PTO start the date you're hired with no waiting period!
This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization.
Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThis employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Top Skills
What We Do
Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, its product portfolio includes injectables, devices and skin care treatments designed to meet each patient’s needs with high standards of safety and efficacy. Being family owned for more than 115 years, Merz Aesthetics is known for building unique connections with customers who feel like family. Merz Aesthetics’ global headquarters is in Raleigh, N.C., USA, with a commercial presence in 90 countries worldwide. It is also a part of Merz Group, which was founded in 1908 and is based in Frankfurt, Germany. Learn more at merzaesthetics.com.
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